Retrofitted neural injection system and related methods

ABSTRACT

Various embodiments may include methods of manufacture of a retrofitted neural injection system. Various embodiments may include acquiring an injection needle comprising a hollow cannula with an open distal end. Then, forming an at least one side port in the hollow cannula proximate to the distal end. Then, sealing the open distal end of the hollow cannula with a bio-compatible sealant so as to eliminate fluid communication between the inside and the outside of the hollow cannula via the distal end. In some embodiments, the bio-compatible sealant may be comprised of a thermosetting material. In some embodiments, the bio-compatible sealant may be comprised of a cured epoxy resin. In some embodiments, the bio-compatible sealant may be comprised of an aliphatic polymer. In some embodiments, the bio-compatible sealant may be comprised of an polyfluorocarbon.

FIELD OF INVENTION

The present invention generally relates to injection systems and relatedmethods of manufacture and use.

BACKGROUND OF THE INVENTION

Needles and needle systems are used extensively in a wide variety ofprocedures which are performed in various fields of medicine, such ascardiology, radiology, urology, interventional pain management, andinternal medicine. The use of needles and needle systems in invasiveprocedures in various medical fields has become routine due, in part, tothe ability of needles to pass through most tissues without causingsignificant destruction to the tissues. Conventional needles have anorifice or a port at the distal tip of the needle. Distal tips ofneedles are more liable to clog as the tip of the needle is used forpenetration of tissue to access the site of treatment. Additionally,there exists a greater chance of leakage of the agent being delivered,using conventional needles. Needles with orifices located along thelength of the needle are routinely used for aspiration purposes as wellas for delivering anesthesia. Specifically, a variety of needles havingside ports are used for delivery of spinal anesthesia. Thisconfiguration reduces the chance of the inability to deliver anesthesiadue to clogging of the opening at the needle tip.

A very successful embodiment of a needle with an opening at the distalend portion and with a side port is disclosed in U.S. Pat. No. 5,817,074(“the '074 patent”). The '074 patent discloses a stellate ganglionsympathetic block needle having a side port positioned at apredetermined distance from the opening a the distal tip. The stellateganglion sympathetic block needle allows for an effective stellateganglion sympathetic block even if the needle is placed such that theneedle distal opening is under the anterior longitudinal ligament, whichresults in the needle distal opening being, constricted, therebyinterfering with the injection of the anesthesia. When this interferenceoccurs, the side port of the stellate ganglion sympathetic block needleallows directional injection onto the surface of the anteriorlongitudinal ligament in order to spread onto the surface of the longuscoli muscle toward the stellate ganglion, thereby achieving an effectivestellate ganglion sympathetic block. This invention has found wideapplicability; however, certain procedures might prefer a needle with ablocked distal tip and only side port(s) for the administration oftherapeutic, diagnostic or prophylactic agents while retaining the sharppoint of the distal tip to maneuver and penetrate certain tissues toaccess treatment sites.

Needles with a blocked tip (distal end) and an open side portal are usedfor procedures such as thoracentesis, which involves inserting theneedle through the thoracic cage into the pleural space between the lungand the chest wall to draw off fluid for diagnostic or therapeuticpurposes. Thoracentesis needles generally consist of an orifice free,sharp conical end and a circular side hole for draining fluid. However,these needles are pre-made with an enclosed end, making them much moreexpensive than traditional open-ended beveled needles to manufacture.

Accordingly, it would be desirable to create a neural injection systemthat is primarily composed of a traditional open-ended needle system,which is common and inexpensive, and retrofit such a needle to provide asharp-tipped, open side port, closed distal end, neural injectionsystem.

SUMMARY OF THE INVENTION

The summary of the invention is not intended to represent eachembodiment or every aspect of the present invention.

Various embodiments may include a neural injection system comprising: anat least partially hollow cannula with a sharp distal end, wherein saiddistal end has a port comprising biocompatible sealant; wherein saiddistal end has a port, and said partially hollow cannula is defined by afirst inside diameter, a first outside diameter, a first length, and atleast one side port in fluid communication between the inside and theoutside of the hollow cannula, located coaxially at a predetermineddistance from the distal end, wherein the port at the distal end issealed to eliminate fluid communication between the inside and theoutside of the hollow cannula via the distal end.

Further, various embodiments may include a method of treatment for anindividual in need thereof comprising locating a site for treatment inthe individual; adjusting the neural injection system described above;such that the system is positioned relative to the individual at adesired insertion point and orientation; inserting at the site at leasta portion of the neural injection system described above; maneuveringthe distal end of the neural injection system inside the individualproximate to the site; and treating the individual.

Another embodiment may include a method of retrofitting a needlecomprising acquiring an injection needle comprising a hollow cannulawith an open distal end; forming at least one side port in the hollowcannula proximate to the distal end so as to permit fluid communicationbetween the inside and the outside of the hollow cannula via the sideport; and sealing the open distal end of the hollow cannula with asealant so as to eliminate fluid communication between the inside andthe outside of the hollow cannula via the distal end.

Various embodiments may also include a system for delivering an agent invivo in an individual in need thereof comprising: means for locating asite for delivery in the individual; means for adjusting the neuralinjection system described above; such that the system is positionedrelative to the individual at a desired insertion point and orientation;means for inserting at said site at least a portion of the neuralinjection system of claim 1; means for maneuvering the distal end of theneural injection system inside the individual proximate to the site; andmeans for delivering said agent.

Yet another embodiment may be a kit comprising the neural injectionsystem described above; and at least one agent, where the agent may be atherapeutic agent, a diagnostic agent or a prophylactic agent.

The foregoing has outlined rather broadly the features and technicaladvantages of the present invention in order that the detaileddescription of the invention that follows may be better understood.Additional features and advantages of the invention will be describedhereinafter which form the subject of the claims of the invention.

BRIEF DESCRIPTION OF THE FIGURES

The foregoing summary as well as the detailed description of thepreferred embodiment of the invention will be better understood whenread in conjunction with the appended drawings. It should be understood,however, that the invention is not limited to the precise arrangementsand instrumentalities shown herein. The components in the drawings arenot necessarily to scale, emphasis instead being placed upon clearlyillustrating the principles of the present invention. Moreover, in thedrawings, like reference numerals designate corresponding partsthroughout the several views.

The invention may take physical form in certain parts and arrangement ofparts. For a more complete understanding of the present invention, andthe advantages thereof, reference is now made to the followingdescriptions taken in conjunction with the accompanying drawings, inwhich:

FIG. 1 is an illustration of a traditional injection system found in theprior art;

FIG. 2 is an illustration of an embodiment of a retrofitted neuralinjection system; and

FIGS. 3 is an illustration of an embodiment of a retrofitted neuralinjection system with a rigid bend in the cannula.

DETAILED DESCRIPTION OF THE INVENTION

The principles of the present invention and their advantages are bestunderstood by referring to FIGS. 1-3 of the drawings, like numeralsbeing used for like and corresponding parts of the various drawings.

Although the invention has been described with reference to specificembodiments, these descriptions are not meant to be construed in alimiting sense. Various modifications of the disclosed embodiments, aswell as alternative embodiments of the invention will become apparent topersons skilled in the art upon reference to the description of theinvention. It should be appreciated by those skilled in the art that theconception and the specific embodiment disclosed may be readily utilizedas a basis for modifying or designing other structures for carrying outthe same purposes of the present invention. It should also be realizedby those skilled in the art that such equivalent constructions do notdepart from the spirit and scope of the invention as set forth in theappended claims.

In the following descriptions and examples, specific details are setforth such as specific quantities, sizes, etc., to provide a thoroughunderstanding of the present invention. However, it will be obvious tothose skilled in the art that the present invention may be practicedwithout such specific details. In many cases, details concerning suchconsiderations and the like have been omitted inasmuch as such detailsare not necessary to obtain a complete understanding of the presentinvention and are within the skills of persons of ordinary skill in therelevant art. It is therefore contemplated that the claims will coverany such modifications or embodiments that fall within the true scope ofthe invention.

The following definitions and explanations are meant and intended to becontrolling in any future construction unless clearly and unambiguouslymodified in the following examples or when application of the meaningrenders any construction meaningless or essentially meaningless. Incases where the construction of the term would render it meaningless oressentially meaningless, the definition should be taken from Webster'sDictionary, 3 ^(rd) Edition.

The term “attached,” or any conjugation thereof describes and refers theat least partial connection of two items.

Exemplary, non-limiting embodiments of medical instrument, neuralinjection systems, and the like that can be modified according tovarious teachings include, but are not limited to, U.S. Pat. No.6,949,087; U.S. Pat. No. 6,855,132; U.S. Pat. No. 6,558,353; U.S. Pat.No. 6,547,769; U.S. Pat. No. 6,387,163; U.S. Pat. No. 6,245,044; U.S.Pat. No. 5,871,470; U.S. Pat. No. 5,865,806; U.S. Pat. No. 5,836,914;U.S. Pat. No. 5,817,074; U.S. Pat. No. 5,800,445; U.S. Pat. No.5,730,749; U.S. Pat. No. 5,669,882; U.S. Pat. No. 5,628,734; U.S. Pat.No. 5,573,519; U.S. Pat. No. 5,571,091; U.S. Pat. No. 5,480,389; U.S.Pat. No. 5,466,225; U.S. Pat. No. 5,336,191; U.S. Pat. No. 5,312,360;U.S. Pat. No. 5,304,141; U.S. Pat. No. 5,250,035; U.S. Pat. No.5,242,410; U.S. Pat. No. 5,106,376; U.S. Pat. No. 4,994,034; U.S. Pat.No. 4,973,313; U.S. Pat. No. 4,629,450; U.S. Pat. No. 4,317,445; U.S.Pat. No. 4,308,875; U.S. Pat. No. 4,230,123; U.S. Pat. No. 3,856,009;U.S. Pat. No. 3,565,074; and, U.S. Pat. No. 2,922,420, the contents ofwhich are hereby incorporated by reference as if they were presentedherein in their entirety. In general, any catheter may be used with thevarious embodiments of the present invention.

A “fluid” is a continuous, amorphous substance whose molecules movefreely past one another and that has the tendency to assume the shape ofits container, for example, a liquid or a gas.

Any agent that can be injected through a needle can be delivered usingthe inventive method. Typical agents might include drugs, smallmolecules, pharmaceutical agents, diagnostic agents, biologicalmolecules, proteins, peptides, antibodies, polynucleotides, RNA, DNA,viruses, cells, and combinations thereof. Agents may range in size fromsmall organic molecules to macromolecules such as DNA to intact cells.The agent to be delivered to the injection site may be therapeutic (e.g., chemotherapeutic drug, antibiotic), prophylactic (e. g., vaccine),or diagnostic (e. g., contrast agent for magnetic resonance imaging,labeled metabolite).

Drugs include any compound useful in the treatment or prevention of adisease. In a particularly preferred embodiment, the drug is anantibiotic, anti-viral agent, anesthetic, steroidal agent,anti-inflammatory agent, anti-neoplastic agent, antigen, vaccine,antibody, decongestant, antihypertensive, sedative, birth control agent,progestational agent, anti-cholinergic, analgesic, anti-depressant,anti-psychotic, p-adrenergic blocking agent, diuretic, cardiovascularactive agent, vasoactive agent, non-steroidal anti-inflammatory agent,nutritional agent, etc. A combination of drugs may be used in thepresent invention. The drug may also be delivered in various forms, forexample, the drug may be encapsulated, or the drug may be in a timerelease form.

Therapeutic prophalytic or diagnostic agents to be delivered may alsoinclude biological molecules such as proteins, peptides,polynucleotides, and oligonucleotides. Examples of proteins or peptidesinclude insulin, cytokines, growth factors, erythropoeitin, antibodies,antibody fragments, etc. Polynucleotides may be delivered for genetherapy and anti-sense therapy.

In addition to drugs, small molecules, and biological molecules, theinvention may be used to deliver viruses and cells. Particularlypreferred viruses and cells are those that are therapeutic. Viruses withaltered genomes may be used in gene therapy as vectors to introduce aforeign gene into the patient's cells.

Further, agents used for delivery with the inventive method disclosedherein may also include cells. Any type of cell or mixture of cells maybe transplanted using the inventive method.

The term “medicament(s)” means and refers to all types of fluidicsubstances that have a beneficial, desired or therapeutic effect.Non-limiting examples of medicaments suitable for use in the inventionmethods include anesthesia, biologically active agents, such as smallmolecule drugs, proteinaceous substances, polynucleotides or nucleicacids (e.g., heterologous DNA, or RNA) and vectors, liposomes, and thelike, containing such nucleic acids or polynucleotides, as well asliquid preparations or formulations thereof.

The term “medical instrument” means and refers to any item, instrumentor structure capable of connecting to a catheter, such as, but notlimited to a stimulation device, tubing, piping, a medicament deliverysystem, a meter, a liquid repository (e.g., an I.V. bag), a syringe, orthe like.

The term “normal insertion procedure” means and refers to a typicalsurgical or insertion procedure as disclosed in Heavner et al., “SharpVersus Blunt Needle: A Comparative Study of Penetration of InternalStructures and Bleeding in Dogs”, 2003, World Institute of Pain, PainPractice, 3:3, 226-231.

The term “stylet” means and refers to a small poniard. Stylets of thepreset invention are capable of being hollow, but such is not required.

Other than in the operating examples, or where otherwise indicated, allnumbers expressing quantities of ingredients or reaction conditions usedherein are to be understood as modified in all instances by the term“about”.

Various embodiments include a retrofitted neural injection systems andrelated methods of manufacture and use with at least one benefit ofenhanced injection characteristics, increased operational efficiency,reduced cost per unit, reduced incidence of injury through intraneuralor intravascular injection, reduced incidence of injury through prickingor piercing, or the like.

Various embodiments includes a retrofitted neural injection systeminclude an at least partially hollow cannula. The cannula is defined bya first inside diameter, a first outside diameter, a first length, aside port located coaxially along the cannula for fluid communicationbetween the inside and the outside of the hollow cannula, and a sealeddistal end. In some embodiments, the system also includes a stylet,wherein the stylet is capable of being releasably locked in a firstposition within the hollow cannula and extends up to a first length ofthe hollow cannula. In some embodiments, the hollow cannula proximate tothe distal end includes a rigid bend so as to facilitate placement ofthe distal end adjacent to a target site.

Various embodiments also includes methods and devices that are designedfor injection of minute amounts of fluid medicaments into tissue or abody wall, for example, an interior body wall. The therapeutic amount ofthe medicament to be administered according to the invention method willvary depending upon the therapeutic goal to be accomplished, the sizeand age of the subject, the pharmacokinetics of the injectate, and thelike.

Various embodiments are designed for treatment of a target tissue(s) ata target site. In an embodiment, treatment of a tissue may be at leastone of probing, ablation, stimulating, or the like. In general,treatments capable with various embodiments can be any treatment commonin the art and should not be limited by the present disclosure.

A cannula associated with various embodiments may be a cylindricalstructure extending from a proximal end to a distal end. The length fromthe proximate end to the distal end, traveling along the length of thecannula is known as the first length. In various embodiments where abend in the cannula exists, the first length may be longer than thelinear distance from the proximate end to the distal end. In anembodiment, the cannula is of a generally constant circumference. Thecannula is capable of being differentiated by an inside diameter and anoutside diameter. In an embodiment, an outside diameter is between about0.0355 to about 0.03600 mm and an inside diameter is between about0.0230 to about 0.0245 mm. In an alternate embodiment, an outsidediameter between about 0.0205 to 0.280 mm and an inside diameter betweenabout 0.0155 to 0.0170 mm. In various embodiments, an inside diameterand an outside diameter are capable of being any desired length and anyparticular length should not be construed as a limitation on the scopeof the appended claims.

In various embodiments, a distal end of the at least partially hollowcannula may take various shapes. In an embodiment, the distal tip may bethe traditional beveled angular plane shape. In another embodiment, thedistal tip is squared with the perpendicular of the lengthwise plane ofthe cannula. In another embodiment, the distal tip forms a partialbevel, wherein the leading portion of the shaped tip is of a traditionalbevel form and the remainder of the tip is formed in a non-beveledshape, such as a stair step. Regardless of the shape of the distal endof the cannula, the distal end of the cannula should be capable of beingsealed by a material so as to close the original open distal end of thecannula.

In various embodiments, a sealant is applied to provide a hermetic sealat the distal end of the at least partially hollow cannula. The seal maybe used to block all fluid flow through the formerly open distal end ofthe cannula. In various embodiments, the sealant may be applied in amoderate amount so that the cutting and leading action of the distal tipis not encumbered by a buildup of sealant on the distal tip. In variousembodiments, the sealant may be applied in a moderate amount so that theside port is not encumbered or blocked. In some embodiments, the sealantis composed of a bio-compatible material, such as a thermosettingpolymer like an epoxy resin. Aliphatic polymers such as polyethylene orpolypropylene may be applied in a liquid form and cooled to a solidstate on the distal end of the hollow cannula or in monomer form andcured on the surface of the hollow cannula so as to provide a thin yetresistant film across the open end of the distal end. Another sealantthat may be used would be one comprised of a polyfluorocarbon toincrease the “slipperiness” of the leading surface. Other sealantmaterials that may be used are known to those familiar in the medicalarts.

In various embodiments, a connector may be about the proximal end of thecannula. A connector may be used as an attachment means for attachingthe cannula and an optional further medical instrument. Theconnection(s) at the proximal end may be any type of connection commonin the art, such as, for example, and not by way of limitation, a luerlock connector, a threaded attachment, an interference fit attachment, aclamp, a system utilizing a dowel, two or more of the aforesaid incombination, or the like.

A stylet of various embodiments may extend through at least a portion ofthe hollow portion of the cannula. In some embodiments, a stylet may becharacterized by an outside diameter and a length extending from aproximal end to the distal end, representing the first length. Theoutside diameter, in various embodiments, is smaller than the firstinside diameter of the cannula. In some embodiments, the styletcomprises a side port an is at least partially hollow. In an embodiment,the stylet and the cannula define a passageway for passage of at leastone medicament.

In various embodiments, the material of construction may permit thestylet so as to bend within the hollow cannula to conform generally toits internal shape. In some embodiments, the material of construction ofthe flexible stylet may be of a polymer material. In some embodiments,the material will be made of a biocompatible material. Examples of suchembodiments include materials such as polyethylene, polypropylene, andpolyfluorocarbons. In some alternative embodiments, the material ofconstruction may be of a metallic material. Examples of embodimentsinclude steel alloys, titanium alloys, and aluminum. In variousembodiments, the stylet exhibits elastic deformation in regards toinsertion and removal from the cannula.

In various embodiments, the stylet may be capable of being inserted intothe cannula so that the distal tip of the stylet may be position withinthe cannula at any point. In an embodiment, the distal end of the styletmay be positioned so that the distal end of the stylet is equivalentwith the distal end of the cannula in relation to the proximate end ofthe cannula. In an alternate embodiment, the distal end of the styletmay extend past the distal end of the cannula. In an alternateembodiment, the distal end of the cannula may extend past the distal endof the stylet.

Various embodiments may fixedly connect, releasably connect, or leaveunconnected the flexible stylet and the cannula. In another embodiment,the stylet is capable of sliding within the cannula. In anotherembodiment, the stylet is releasably secured within the cannula by alocking mechanism, such as, but not limited to a luer lock, aninterference fit, a snap, screw threads, or the like. In an embodimentof a luer lock system, internal male luer threads are located in orabout the stylet adjacent to receive and engage a cannula having femaleluer threads thereon. In other embodiments, the luer lock is reversed.In another embodiment, the stylet is welded to or otherwise fixedlyconnected to the cannula.

A side port in various embodiments may be a port extending from theexterior of the hollow cannula to the interior of the hollow cannula orthe flexible stylet. The shape of the side port may vary. In anembodiment, a port may be circular. In another embodiment, a port may beovular. In an another embodiment, a port may be a quadrangular port,such as a rectangle or a square. In an another embodiment, the port istriangular. It can be seen by one skilled in the art that the shape ofthe port may be formed in any shape sufficient to permit fluidaspiration.

A side port in various embodiments may be further characterized by theassociated edge of the port on the cannula or stylet. In an embodiment,a port may have a slightly inwardly beveled edge extending from theexterior surface of the hollow cannula to the interior surface. In analternate embodiment, a port may have a slightly outwardly beveled edgeextending from the interior surface of the hollow cannula to theexterior surface. In an embodiment, the degree of bevel may be used tochange the pressure of the medicament as it enters the target tissue,facilitate a change in the degree of spread of the medicament, and allowfor a smooth surface as the cannula is inserted to the target tissue.

Further embodiments may comprise a cannula or stylet with multiple portsarranged in any orientation about the shaft. In an embodiment, a styletmay comprise, in application, a side port across a cannula and a sideport across the stylet. In various embodiments, the side ports may bepositioned such that reasonable alignment of the side ports occurs at adesired position of the stylet within the cannula such that a medicamentmay pass from across the reasonably aligned side ports.

Various embodiments may include a wire or other means of conveyingstimulation to a target tissue. In an embodiment, the wire may extendsalong the cannula from about the proximal end to about the distal end ofthe distal tip. In another embodiment, the wire may be integral(attached to) with the cannula. In another embodiment, the wire mayextend along the outside of the cannula. In another embodiment, a wiremay extend along, through, or is integral with the stylet.

Design consideration that may be implemented with various embodimentsinclude, but are not limited, to designing the wire and connector suchthat they may be utilized as a “plug and use” type of arrangement. Aplug and use arrangement is beneficial because it reduces the complexityof the device and reduces loose wires. In an embodiment, the wire may beformed into the connector such that when the connector is connected toanother medical instrument, the wire is able to communicate with theinstrument. However, any connection common in the art that would allowthe wire to communicate with a medical instrument may be contemplatedwithin various embodiments.

Various embodiments may include insulation or at least one forminsulation about the cannula, stylet, or wire. As may be appreciated byone of ordinary skill in the art, any material of construction thatprovides electrical or thermal insulation could be used such as, but notlimited to, a plastic, a rubber, a metal, a non-metal, or the like. Insome embodiments, the insulation covers the exterior of the hollowcannula along the entire first length. In some embodiments, theinsulation covers the exterior of the hollow cannula until it reachesthe rigid bend portion of the hollow cannula. In some embodiments, theinsulation covers an exterior portion of the hollow cannula in betweenthe hub and the rigid bend portion.

Various embodiments may include insulation around the hollow cannula,flexible stylet, or wire that is constructed of a material that permitsdifferentiation between the insulation and the hollow cannula orflexible stylet material during real-time procedural use. Numerousprocedures, such as, but not limited to, fluoroscopic guidanceprocedures, NMR procedures, X-ray procedures, direct viewing procedures,or the like, may be used during a medical procedure to determine theposition of a retrofitted neural injection system and the targetlocation. In such embodiments, a practitioner may choose an embodimentwith an insulation coating wherein the absorptive or reflectivedifference between the insulation coating and the uninsulated portion ofthe retrofitted neural injection system can be differentiated inreal-time using the selected real-time viewing system. For example, aparticular insulation may absorb the energy from a real-time viewingsystem and show up as a dark segment whereas the uninsulated portion mayreflect the energy and appear to be a bright segment. In suchembodiments, the differentiation in reflectivity and absorption mayprovide a method to determine the exact position of the shaped tip, thedistal tip, or the side portal of the retrofitted neural needle inrelation to the treatment site, given that the relative distance fromthe insulation/non-insulation border.

Further modifications of embodiments of a retrofitted injection systemwith a wire comprise the introduction of a probe about the shaft orwire. Various probes capable of use with embodiments include temperatureprobes, stimulation probes, cameras, or the like.

Various embodiments may include methods of manufacture of a retrofittedneural injection system. Various embodiments may include acquiring aninjection needle comprising a hollow cannula with an open distal end. Insome embodiments, the open distal end is shaped in a beveled form. Then,forming a side port in the hollow cannula proximate to the distal end soas to permit fluid communication between the inside and the outside ofthe hollow cannula via the newly formed side port. In some embodiments,a plurality of side ports are formed. Formation of a side port in thehollow cannula of the injection needle may be performed using any numberof methods known to ones of ordinary skill in the art. Then, sealing theopen distal end of the hollow cannula with a bio-compatible sealant soas to eliminate fluid communication between the inside and the outsideof the hollow cannula via the distal end. In some embodiments, thebio-compatable sealant may be comprised of a thermosetting material. Insome embodiments, the bio-compatible sealant may be comprised of a curedepoxy resin. In some embodiments, the bio-compatible sealant may becomprised of an aliphatic polymer. In some embodiments, thebio-compatible sealant may be comprised of an polyfluorocarbon.Handling, applying, and curing the sealant may be performed using anynumber of techniques known to one skilled in the art. In someembodiments, the sealant does not hinder the penetrating or leadingoperation of the distal end of the hollow cannula. Then, in someembodiments, the hollow cannula is forcibly bent so as to impart a rigidbend. Then, in some embodiments, a stylet is included. Then, in someembodiments, a wire is included. Then, in some embodiments, insulationis included.

Various embodiments may include methods of use of a retrofittedinjection system. An embodiment of a method may include locating a sitefor treatment in a patient. Then, inserting into a patient at least aportion of a retrofitted injection system comprised of an at leastpartially hollow cannula being defined by a first inside diameter, afirst outside diameter, a first length, a side port located coaxiallyalong the hollow cannula for fluid communication between the inside andthe outside of the hollow cannula, and a sealed distal end. In someembodiments, a stylet, wherein the stylet is capable of being releasablylocked in a first position within the hollow cannula and extends up to afirst length of the hollow cannula, is included. In some embodiments,the hollow cannula proximate to the distal end includes a rigid bend soas to facilitate placement of the distal end about the treatment site.Then, maneuvering the distal end of the retrofitted neural injectionsystem inside a patient proximate to the treatment site. Then, treatingthe patient.

Further embodiments of a method may include stimulating a tissue.Further embodiments of a method may include ablating at least a portionof the tissue about a site. Other embodiments comprise probing a tissue.And yet further embodiments of a method may include preparing a patientfor administering a medicament.

In an embodiment of an administration of a block, such as a nerve block,the method may comprise preparing the patient. In an embodiment,preparing the patient may comprise placing a patient in a supineposition or extended position, without a pillow, with the patient's headin a neutral position.

In an embodiment of administration of a medicament, while standing onside of the body that is to be blocked, the physician may tactilelylocates the cricoid cartilage. In such an embodiment, the neuralinjection system may be inserted in a position approximately one fingerbreadth below the cricoid cartilage, between the carotid sheath and thetrachea on the side to be blocked, while aiming slightly medially untilbony contact is made with the ventral lateral side of the body of theseventh cervical vertebra. When the neural injection system is in saidposition, the anesthesia may be injected.

In another embodiment, there may be methods for injecting a medicamentinto tissue of a subject. The method may include inserting the distalportion of an embodiment into the tissue of the subject and causing atherapeutic amount of medicament to enter multidirectionally from adistal end into the tissue.

FIG. 1 illustrates an embodiment of a traditional injection system 1.The traditional injection system 1 is comprised of a cannula 10. Thecannula 10 is capable of being characterized as having a first length asmeasured from the proximate end of a stylet mating hub 44 to a distalopening 46 of the distal tip 40. The distal tip 40 in this example is ina beveled shape at the end of a hollow cannula shaft 34. A stylet matinghub 44, wherein a stylet 20 may be insertedly attached to the cannula10, is present on the proximate end of the cannula 10. The stylet matinghub 44 possesses a stylet receiving notch 60 to fixedly engage acorresponding tab 58 on a stylet 20.

FIG. 2 is an illustration of an embodiment of a retrofitted neuralinjection system 2. The retrofitted injection system 2 is comprised ofsimilar components as the traditional injection system 1. Retrofittedneural injection system 2 is also comprised of a side port 48, which inFIG. 2 is embodied in a small rounded hole. Retrofitted neural injectionsystem 2 is also comprised of a distal opening 46 that is sealed closed.This permits fluid communication between the inside and the outside ofthe hollow cannula shaft 34 only by the side port 48 instead of by thedistal opening 46 as in the traditional injection system 1.

FIGS. 3 is an illustration of an embodiment of a retrofitted neuralinjection system 3 with a rigid bend in the cannula. The retrofittedinjection system 3 is comprised of similar components as the traditionalinjection system 1 and retrofitted neural injection system 2.Retrofitted neural injection system 3 is also comprised of rigid bentportion 38 proximate to the side port 48, which in FIG. 3 is embodied ina quadrangle hole. Retrofitted neural injection system 3 is alsocomprised of insulation 36 along part of the hollow cannula shaft 34.

As such, various embodiments of the present invent tion generallycompriuse methods of retrofitting a needle comprising acquiring aninjection needle comprising a hollow cannula with an open distal end;forming at least one side port in the hollow cannula proximate to thedistal end so as to permit fluid communication between the inside andthe outside of the hollow cannula via the side port; and sealing theopen distal end of the hollow cannula with a sealant so as to eliminatefluid communication between the inside and the outside of the hollowcannula via the distal end.

Various further embodiments therefore comprise a retrofitted neuralinjection system comprising an at least partially hollow cannula with asharp distal end, wherein said distal end has a port, and said partiallyhollow cannula is defined by a first inside diameter, a first outsidediameter, a first length, and at least one side port in fluidcommunication between the inside and the outside of the hollow cannula,located coaxially at a predetermined distance from the distal end,wherein the port at the distal end is sealed to eliminate fluidcommunication between the inside and the outside of the hollow cannulavia the distal end.

Various further embodiments comprise a method of treatment for anindividual in need thereof comprising locating a site for treatment insaid individual; adjusting the retrofitted neural injection system asdescribed herein; such that said system is positioned relative to saidindividual at a desired insertion point and orientation; inserting atsaid site at least a portion of said retrofitted neural injectionsystem; maneuvering the distal end of the retrofitted neural injectionsystem inside said individual proximate to the site; and treating saidindividual.

Although the present invention is described with several embodiments,various changes and modifications may be suggested to one skilled in theart. In particular, the present invention is described with reference tocertain polymers and materials and methods of processing thosematerials, but may apply to other types of processing or materials withlittle alteration and similar results. Furthermore, the presentinvention contemplates several process steps that may be performed inthe sequence described or in an alternative sequence without departingfrom the scope and the spirit of the present invention. The presentinvention is intended to encompass such changes and modifications asthey fall within the scope and the spirit of the appended claims.

What is claimed is:
 1. A neural injection system comprising: an at leastpartially hollow cannula with a sharp distal end, wherein said sharpdistal end has a port comprising biocompatible sealant, wherein saidport was formerly open; wherein said hollow cannula is defined by afirst inside diameter, a first outside diameter, a first length, and atleast one side port in fluid communication between the inside and theoutside of the hollow cannula; wherein said side port is locatedcoaxially at a predetermined distance from the distal end; and whereinfluid communication between the inside and the outside of the hollowcannula via the distal end is eliminated by a hermetic seal.
 2. Thesystem of claim 1, wherein the neural injection system comprises astylet.
 3. The system of claim 2, wherein the stylet is releasablysecured within a first portion of said hollow cannula.
 4. The system ofclaim 2, wherein the stylet is fixedly secured within a first portion ofsaid hollow cannula.
 5. The system of claim 2, wherein the stylet iscapable of sliding within said hollow cannula.
 6. The system of claim 2,wherein the stylet extends up to the distal end of said first length ofsaid hollow cannula.
 7. The system of claim 2, wherein the styletextends beyond the distal end of said first length of said hollowcannula.
 8. The system of claim 2, wherein the stylet is hollow and hasat least one side port.
 9. The system of claim 8, wherein the side portof said stylet is in fluid communication with said side port of thehollow cannula.
 10. The system of claim 9, wherein the neural injectionsystem comprises a rigid bend in the hollow cannula proximate to thedistal end.
 11. The system of claim 10, further comprising an agent fordelivery to said individual.
 12. A method of treatment of an individualin need thereof comprising: locating a site for treatment in saidindividual; adjusting the neural injection system of claim 4 such thatsaid system is positioned relative to said individual at a desiredinsertion point and orientation; inserting at said site at least aportion of said neural injection system; maneuvering the distal end ofthe neural injection system inside said individual proximate to thesite; and treating said individual.
 13. A kit comprising the neuralinjection system of claim 4 and at least one agent.